Trial Outcomes & Findings for Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase (NCT NCT03985813)

Last Updated: 2022-07-15

Results Overview

The rate of personalized referrals by primary care providers and treatment initiation among adolescents who screen positive for depression or suicidal ideation will be monitored to determine if provider made referral as recommended on intervention report. This initial outcome has been modified as a result of the changes in study design.

Recruitment status

COMPLETED

Study phase

Target enrollment

53 participants

Primary outcome timeframe

Baseline (in office) visit

Results posted on

2022-07-15

Participant Flow

Some participants were enrolled into the TAU arm prior to converting from a stepped wedge design to an open design.

Participant milestones

Participant milestones
Measure	Screening Wizard Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.	Treatment As Usual (TAU) Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals.
Overall Study STARTED	27	26
Overall Study COMPLETED	27	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Screening Wizard n=27 Participants Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.	Treatment As Usual (TAU) n=26 Participants Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals.	Total n=53 Participants Total of all reporting groups
Age, Categorical <=18 years	10 Participants n=5 Participants	26 Participants n=7 Participants	36 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	0 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Gender · Male	7 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants
Sex/Gender, Customized Gender · Female	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Sex/Gender, Customized Gender · Male to Female Transgender	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex/Gender, Customized Gender · Female to Male Transgender	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	13 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	26 participants n=7 Participants	53 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (in office) visit

Population: The number analyzed for each row differs from overall number analyzed as each row is broken into subcategories of recommendations. Not all participants received a specific recommendation. TAU results are recommendations that would have been made based on Screening Wizard algorithm.

Outcome measures

Outcome measures
Measure	Screening Wizard n=33 Recommendations Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.	Treatment As Usual (TAU) n=33 Recommendations Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals.
Personalized Referral All recommendations combined · Agree with recommendation	22 Recommendations	15 Recommendations
Personalized Referral All recommendations combined · Disagree with recommendation	11 Recommendations	18 Recommendations
Personalized Referral Watchful Waiting recommendation · Agree with recommendation	8 Recommendations	10 Recommendations
Personalized Referral Watchful Waiting recommendation · Disagree with recommendation	2 Recommendations	0 Recommendations
Personalized Referral Ask parent further questions recommendation · Disagree with recommendation	0 Recommendations	0 Recommendations
Personalized Referral Conduct a safety plan assessment recommendation · Disagree with recommendation	5 Recommendations	12 Recommendations
Personalized Referral Refer to embedded therapist recommendation · Agree with recommendation	1 Recommendations	2 Recommendations
Personalized Referral Refer to embedded therapist recommendation · Disagree with recommendation	2 Recommendations	4 Recommendations
Personalized Referral Substance use referral recommendation · Disagree with recommendation	1 Recommendations	0 Recommendations
Personalized Referral No treatment needed, rescreen if concern for non-disclosure recommendation · Disagree with recommendation	0 Recommendations	0 Recommendations
Personalized Referral Tobacco counseling recommendation · Agree with recommendation	0 Recommendations	0 Recommendations
Personalized Referral Refer to severe anxiety clinic recommendation · Agree with recommendation	1 Recommendations	0 Recommendations
Personalized Referral Refer to severe anxiety clinic recommendation · Disagree with recommendation	0 Recommendations	0 Recommendations
Personalized Referral Refer to mania clinic recommendation · Agree with recommendation	0 Recommendations	0 Recommendations
Personalized Referral Refer to mania clinic recommendation · Disagree with recommendation	0 Recommendations	1 Recommendations
Personalized Referral Ask parent further questions recommendation · Agree with recommendation	1 Recommendations	0 Recommendations
Personalized Referral Conduct a safety plan assessment recommendation · Agree with recommendation	0 Recommendations	0 Recommendations
Personalized Referral Recommend referral to specialty depression clinic to evaluate suicidality · Agree with recommendation	1 Recommendations	0 Recommendations
Personalized Referral Recommend referral to specialty depression clinic to evaluate suicidality · Disagree with recommendation	0 Recommendations	0 Recommendations
Personalized Referral Substance use referral recommendation · Agree with recommendation	0 Recommendations	0 Recommendations
Personalized Referral No treatment needed, rescreen if concern for non-disclosure recommendation · Agree with recommendation	10 Recommendations	3 Recommendations
Personalized Referral Tobacco counseling recommendation · Disagree with recommendation	1 Recommendations	1 Recommendations

SECONDARY outcome

Timeframe: Baseline (phone) visit

Use of the technical components of Screening Wizard will be monitored. Utilization will be measured by the number and proportion of adolescents, parents, and providers who have engaged with the application over time.

Outcome measures

Outcome measures
Measure	Screening Wizard n=27 Participants Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.	Treatment As Usual (TAU) n=26 Participants Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals.
Number of Participants Who Utilized the Screening Wizard Application	27 Participants	26 Participants

SECONDARY outcome

Timeframe: At Baseline phone visit

Population: All participants in both arms responded to CASA questions for Baseline assessment.

The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm.

Outcome measures

Outcome measures
Measure	Screening Wizard n=27 Participants Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.	Treatment As Usual (TAU) n=26 Participants Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals.
Service Use (Number of Participants at Baseline) Use outpatient services	19 Participants	6 Participants
Service Use (Number of Participants at Baseline) Use school services	14 Participants	6 Participants
Service Use (Number of Participants at Baseline) Use ER services	2 Participants	2 Participants
Service Use (Number of Participants at Baseline) Use legal services	1 Participants	0 Participants
Service Use (Number of Participants at Baseline) Use inpatient services	3 Participants	1 Participants
Service Use (Number of Participants at Baseline) Use medications	15 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 4 follow-up after Baseline

Population: All Screening WIzard intervention participants responded to 4 week CASA assessment and 25/26 Treatment As Usual participants responded to 4 week CASA assessment.

The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm.

Outcome measures

Outcome measures
Measure	Screening Wizard n=27 Participants Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.	Treatment As Usual (TAU) n=25 Participants Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals.
Service Use (Number of Participants at 4 Week Follow-up) Use outpatient services	14 Participants	6 Participants
Service Use (Number of Participants at 4 Week Follow-up) Use school services	5 Participants	4 Participants
Service Use (Number of Participants at 4 Week Follow-up) Use ER services	0 Participants	0 Participants
Service Use (Number of Participants at 4 Week Follow-up) Use legal services	0 Participants	0 Participants
Service Use (Number of Participants at 4 Week Follow-up) Use inpatient services	0 Participants	0 Participants
Service Use (Number of Participants at 4 Week Follow-up) Use medications	11 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 12 follow up after Baseline

Population: 26/27 Screening Wizard intervention participants completed CASA assessment and all Treatment As Usual participants completed CASA assessment.

The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm.

Outcome measures

Outcome measures
Measure	Screening Wizard n=26 Participants Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.	Treatment As Usual (TAU) n=26 Participants Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals.
Service Use (Number of Participants at 12 Week Follow-up) Use legal services	0 Participants	1 Participants
Service Use (Number of Participants at 12 Week Follow-up) Use inpatient services	0 Participants	0 Participants
Service Use (Number of Participants at 12 Week Follow-up) Use medications	11 Participants	4 Participants
Service Use (Number of Participants at 12 Week Follow-up) Use outpatient services	13 Participants	7 Participants
Service Use (Number of Participants at 12 Week Follow-up) Use school services	5 Participants	3 Participants
Service Use (Number of Participants at 12 Week Follow-up) Use ER services	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At exit interview after Baseline phone visit. The baseline visit occurs 24-48 hours after initial screening and the exit interview call will be made within 1 month following the completion of the baseline phone assessment.

Population: Out of the 27 participants in the Screening Wizard arm, only 22 answered the satisfaction question at the exit interview. No statistical analysis completed because there is no comparison group.

Satisfaction to Screening Wizard will be assessed through a question developed by investigators to understand experience with the program. The question investigators have adapted from literature reviews on satisfaction is: "If a friend were in need of a mental health referral, would you recommend Screening Wizard to him/her? The response options include: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely.

Outcome measures

Outcome measures
Measure	Screening Wizard n=22 Participants Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.	Treatment As Usual (TAU) Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals.
Usability & Satisfaction No, definitely not	0 Participants	—
Usability & Satisfaction No, I don't think so	6 Participants	—
Usability & Satisfaction Yes, I think so	12 Participants	—
Usability & Satisfaction Yes, definitely	4 Participants	—

SECONDARY outcome

Population: Out of the 27 participants in the Screening Wizard arm, only 19 answered the questions regarding satisfaction with technical components at the exit interview. No statistical analysis completed because there is no comparison group.

Satisfaction with the technical components of interventions will be assessed through certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ). The PSSUQ is 19 items with response options ranging from 1 to 7 where 1=strongly disagree and 7=strongly agree. The PSSUQ has sub-scores derived from subsets of the questions which reflect system usefulness, information quality, and interface quality. Questions from sub-domains were chosen to tailor the questioning to this particular intervention. Another question about the need to learn new things before using the app was asked to be rated on a 1-5 scale, with 1= strongly disagree and 5= strongly agree.

Outcome measures

Outcome measures
Measure	Screening Wizard n=19 Participants Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.	Treatment As Usual (TAU) Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals.
Usability & Satisfaction Overall, I am satisfied with how easy it is to use Screening Wizard	6.2 score on a scale Standard Deviation 1.3	—
Usability & Satisfaction The information such as online help, on-screen messages, and other documentation, provided was clear	6.2 score on a scale Standard Deviation 1	—
Usability & Satisfaction I liked interacting with the Screening Wizard app	5.7 score on a scale Standard Deviation 1.2	—
Usability & Satisfaction I needed to learn a lot of things before I could get going with the Screening Wizard	1.5 score on a scale Standard Deviation 0.7	—

SECONDARY outcome

Timeframe: At Baseline

Population: All 27 participants enrolled engaged in using Screening Wizard intervention.

An overall average of the cost of implementing the Screening Wizard intervention (including labor, equipment, supplies, facilitates) will be estimated at Baseline.

Outcome measures

Outcome measures
Measure	Screening Wizard n=27 Participants Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.	Treatment As Usual (TAU) Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals.
Cost Analysis: Cost of Screening Wizard Intervention at Baseline	160.34 dollars per participant Interval 81.54 to 198.88	—

Adverse Events

Screening Wizard

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment As Usual (TAU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Oliver Lindhiem

University of Pittsburgh

Phone: 4122465909

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place